A Phase 2 interventional study of TRTL-913 and Placebo in Tinnitus, sponsored by Tortugas Neuroscience, Inc.. Recruiting at 10 sites in 2 countries. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Tortugas Neuroscience, Inc. · Phase 2, Interventional, and Treatment
This study will consist of two parts. Double blind Part A will assess the safety, tolerability, and pharmacokinetics of 7 days of dosing in healthy adults, while open label Part B will evaluate the safety, tolerability, and efficacy of a 2-week treatment course in adults with tinnitus.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 368 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →Tortugas Neuroscience, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Part A Inclusion Criteria:
Part B Inclusion Criteria:
Exclusion Criteria:
Part A Exclusion Criteria:
Part B Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive TRTL-913 immediate-release capsules administered once daily (QD) on Day 1 through Day 7.
Drug: TRTL-913
Participants will receive TRTL-913 matching placebo administered QD on Day 1 through Day 7.
Drug: Placebo
Participants will self-administer TRTL-913 immediate-release capsules QD on Day 1 through Day 14. Additional doses will be based on the results from Part A.
Drug: TRTL-913
Participants will receive TRTL-913 capsules QD.
Participants will receive TRTL-913 matching placebo capsules QD.
Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 16
Part B: Number of Participants With TEAEs and SAEs
Time frame: Up to Day 21
Part A: Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and Electrocardiograms (ECGs)
Time frame: Up to Day 16
Part B: Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and ECGs
Time frame: Up to Day 21
Part A: Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 16
Part B: Number of Participants With Suicidal Ideation or Behavior as Assessed by the C-SSRS
Time frame: Up to Day 21
Part A: Plasma Concentrations of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Maximum Observed Plasma Concentration (Cmax) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Time to Maximum Plasma Concentration (Tmax) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Area Under the Plasma Concentration-Time Curve (AUC(0-t)) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: AUC From 0 to 24 Hours (AUC(0-24h)) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: AUC from time 0 extrapolated to infinity (AUC(0-inf)) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Apparent Terminal Elimination Half-Life (t1/2) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Apparent Total Plasma Clearance After Oral Administration (CL/F) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Apparent Volume of Distribution During Terminal Phase (Vz/F) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Accumulation Ratio for AUC (Rac AUC) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Accumulation Ratio for Cmax (Rac Cmax) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part B: Change From Baseline in Tinnitus Functional Index (TFI) Total and Subscale Scores
Time frame: From Baseline to Day 21
Part B: Change From Baseline in Tinnitus Handicap Inventory (THI) Score
Time frame: From Baseline to Day 21
Part B: Change From Baseline in the Visual Analog Scale - Loudness (VAS-L) Score
Time frame: From Baseline to Day 21
Part B: Change From Baseline in Visual Analog Scale - Annoyance (VAS-A) Score
Time frame: From Baseline to Day 21
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Aug 2027, 10 months after the start.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Nov 4, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Tortugas Neuroscience, Inc.